Medical Writing Trends in medical writing The 360° approach to authoring risk management plans

Volume 28, Issue 3 - Trends in medical writing

The 360° approach to authoring risk management plans


Amidst the dynamic landscape of pharma - covigilance legislation, medical writers have been gaining increased visibility and importance beyond what had been their traditional role of coordinating and facil it - ating the development of risk management plans. Over the past couple of years, medical writers have been contributing extensively in driving the seamless integration of the recent Good Pharmacovigilance Practices guidance version 2.0 into companies’ global pharma - covigilance systems, quality assurance systems, and relevant standard operating procedures. A comprehensive “360°” approach adapted by medical writers ensures efficient authoring of high-quality RMPs.

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  3. [Internet]. European Medicines Agency, Guideline on good pharmacovigilance practices (GVP) Module X – Additional monitoring, c2013 [cited 2013 Apr 19] Available from: /scientific-guideline/guideline-goodpharmacovigilance- practices-module-xadditional- monitoring_en.pdf.
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Clinical trial disclosure: Perspective from a medical writer for a contract research organisation
The 360° approach to authoring risk management plans
Trends in regulatory writing: A brief overview for aspiring medical writers
The medical writing landscape in China
News from the EMA
Regulatory Matters
Medical Communications and Writing for Patients
In the Bookstores
Getting Your Foot in the Door
Veterinary Medical Writing
Medical Devices
My First Medical Writing
Journal Watch
Good Writing Practice
Regulatory Public Disclosure
Out on Our Own

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